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The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.
Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment | 2 years after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of local recurrence after surgery | Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years | |
| Rate of distant metastases | Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years |
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Inclusion Criteria:
Histopathologically verified adenocarcinoma of the rectum
Planned abdominoperineal resection (APR) or ultralow resection
Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.
Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope
Performance status 0-2
Patient acceptance to collection of biopsies and blood samples for translational research
Age ≥ 18 years
Normal function of bone marrow as evaluated by
Normal function of liver
Kidney function
- Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) > 30 ml/min
Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
Written and orally informed consent
Exclusion Criteria:
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Patients with low rectal cancer (tumor located ≤ 6 cm from the anal verge) who are referred to the participating departments and who fulfill the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, DMSc | Department of Oncology, Vejle Hospital | Study Chair |
| Henrik Jensen, PhD | Department of Oncology, Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Aalborg University Hospital | Aalborg | Denmark | ||||
| Department of Surgery, Aalborg University Hospital |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination | 6 and potentially 12 weeks after end of treatment |
| Aalborg |
| Denmark |
| Department of Oncology, Rigshospitalet | Copenhagen | Denmark |
| Department of Oncology, Vejle Hospital | Vejle | Denmark |
| Department of Surgery, Vejle Hospital | Vejle | Denmark |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |